Bicara's cancer drug enters crucial trial phase, says CEO Claire Mazumdar

US-based clinical-stage biopharmaceutical company Bicara Therapeutics is expecting its lead drug candidate, a potential first-in-class innovative cancer medicine, to enter a critical phase of clinical trials by mid-next year. Bengaluru-based Biocon Ltd, the company that incubated Bicara, has a 10.1% stake in the NASDAQ-listed entity.

“We're in an exciting phase right now. FORTIFI-HN01, our global, randomized, placebo-controlled pivotal study of ficerafusp alfa in combination with pembrolizumab for first-line HPV-negative recurrent/metastatic head and neck cancer, is ongoing, and we expect to be substantially enrolled by the end of the year to enable an interim analysis in mid-2027 to support potential accelerated approval,” Claire Mazumdar, CEO of Bicara Therapeutics, said.

In an email response to Fortune India, Mazumdar said that earlier this year, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, the company presented extended follow-up data of up to three years from the Phase 1/1b study of ficerafusp alfa in combination with pembrolizumab in the same patient population. The data showed deep, durable responses and meaningfully improved survival compared with the standard of care, underscoring the company's confidence in its Phase 3 clinical trial.

“The Bicara team is focused on executing the trial at a global scale with the goal of bringing ficerafusp alfa to patients in need as quickly as possible,” Mazumdar said.

Ficerafusp alfa is a first-in-class, dual-action, bifunctional EGFR (epidermal growth factor receptor)/TGF-β antibody in clinical development for multiple solid tumor cancer types, including head and neck squamous cell carcinoma (HNSCC), one of the most common and debilitating cancers in the US. HNSCC develops from the mucosal epithelium in the oral cavity, pharynx, and larynx and is the most common malignancy arising in the head and neck. Most cases of HNSCC are thought to result from accumulated mutations caused by carcinogenic exposures such as tobacco smoke or HPV infection. With a rising incidence, HNSCC is anticipated to reach one million new global cases annually by 2030. There are approximately 67,000 cases of HNSCC each year in the US, with a 13% five-year survival rate.

In an investor presentation in May, Bicara said the company had $539.8 million in cash, cash equivalents, and marketable securities (as of March 31, 2026) to fund its operations into the first half of 2029.